Mitral valve regurgitation treatment device and method

ABSTRACT

A method of treating regurgitation of a mitral valve in a patient&#39;s heart. The method includes the steps of: delivering a tissue shaping device to the coronary sinus; and deploying the tissue shaping device to reduce mitral valve regurgitation, the deploying step comprising applying a force through the coronary sinus wall toward the mitral valve solely proximal to a crossover point where a coronary artery passes between a coronary sinus and the mitral valve. The invention is also a set of devices for use in treating mitral valve regurgitation. The set includes a plurality of tissue shaping devices having different lengths, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french.

CROSS-REFERENCE TO RELATED CASES

This application is a continuation-in-part of U.S. patent appl. Ser. No.09/855,945, filed May 14, 2001, the disclosure of which is incorporatedherein by reference.

BACKGROUND OF THE INVENTION

This invention relates generally to devices and methods for shapingtissue by deploying one or more devices in body lumens adjacent to thetissue. One particular application of the invention relates to atreatment for mitral valve regurgitation through deployment of a tissueshaping device in the patient's coronary sinus or great cardiac vein.

The mitral valve is a portion of the heart that is located between thechambers of the left atrium and the left ventricle. When the leftventricle contracts to pump blood throughout the body, the mitral valvecloses to prevent the blood being pumped back into the left atrium. Insome patients, whether due to genetic malformation, disease or injury,the mitral valve fails to close properly causing a condition known asregurgitation, whereby blood is pumped into the atrium upon eachcontraction of the heart muscle. Regurgitation is a serious, oftenrapidly deteriorating, condition that reduces circulatory efficiency andmust be corrected.

Two of the more common techniques for restoring the function of adamaged mitral valve are to surgically replace the valve with amechanical valve or to suture a flexible ring around the valve tosupport it. Each of these procedures is highly invasive because accessto the heart is obtained through an opening in the patient's chest.Patients with mitral valve regurgitation are often relatively frailthereby increasing the risks associated with such an operation.

One less invasive approach for aiding the closure of the mitral valveinvolves the placement of a tissue shaping device in the cardiac sinusand vessel that passes adjacent the mitral valve. The tissue shapingdevice is designed to push the vessel and surrounding tissue against thevalve to aid its closure. This technique has the advantage over othermethods of mitral valve repair because it can be performedpercutaneously without opening the chest wall. Examples of such devicesare shown in U.S. patent appl. Ser. No. 10/142,637, “Body Lumen DeviceAnchor, Device and Assembly” filed May 8, 2002; U.S. patent appl. Ser.No. 10/331,143, “System and Method to Effect the Mitral Valve Annulus ofa Heart” filed Dec. 26, 2002; and U.S. patent appl. Ser. No. 10/429,172,“Device and Method for Modifying the Shape of a Body Organ,” filed May2, 2003. The disclosures of these patent applications are incorporatedherein by reference.

When deploying a tissue shaping device in a vein or artery to modifyadjacent tissue, care must be taken to avoid constricting nearbyarteries. For example, when treating mitral valve regurgitation, atissue shaping device may be deployed in the coronary sinus to modifythe shape of the adjacent mitral valve annulus. Coronary arteries suchas the circumflex artery may cross between the coronary sinus and theheart, however, raising the danger that deployment of the support maylimit perfusion to a portion of the heart by constricting one of thosearteries. See, e.g., the following applications, the disclosures ofwhich are incorporated herein by reference: U.S. patent appl. Ser. No.09/855,945, “Mitral Valve Therapy Device, System and Method,” filed May14, 2001 and published Nov. 14, 2002, as US 2002/0169504 A1; U.S. patentappl. Ser. No. 09/855,946, “Mitral Valve Therapy Assembly and Method,”filed May 14, 2001 and published Nov. 14, 2002, as US 2002/0169502 A1;and U.S. patent appl. Ser. No. 10/003,910, “Focused Compression MitralValve Device and Method” filed Nov. 1, 2001. It is therefore advisableto monitor cardiac perfusion during and after such mitral valveregurgitation therapy. See, e.g., U.S. patent appl. Ser. No. 10/366,585,“Method of Implanting a Mitral Valve Therapy Device,” filed Feb. 12,2003, the disclosure of which is incorporated herein by reference.

BRIEF SUMMARY OF THE INVENTION

The anatomy of the heart and its surrounding vessels varies from patientto patient. For example, the location of the circumflex artery and otherkey arteries with respect to the coronary sinus can vary. Specifically,the distance along the coronary sinus from the ostium to the crossingpoint with the circumflex artery can vary from patient to patient. Inaddition, the diameter and length of the coronary sinus can vary frompatient to patient.

We have invented tissue shaping devices, sets of tissue shaping devicesand methods that maximize the therapeutic effect (i.e., reduction ofmitral valve regurgitation) while minimizing adverse effects, such as anunacceptable constriction of the circumflex artery or other coronaryarteries. The tissue shaping devices, sets of devices and methods ofthis invention enable the user to adapt the therapy to the patient'sanatomy.

In one embodiment, the invention is a method of treating regurgitationof a mitral valve in a patient's heart, the method including the stepsof delivering a tissue shaping device to the coronary sinus, such as ina catheter having an outer diameter no more than nine or ten french; anddeploying the tissue shaping device to reduce mitral valveregurgitation, with the deploying step including the step of applying aforce through the coronary sinus wall toward the mitral valve solelyproximal to a crossover point where a coronary artery passes between acoronary sinus and the mitral valve. In some embodiments, the device isdeployed with its distal end proximal to the crossover point, and insome embodiments the distal end is deployed distal to the crossoverpoint. The method may also include the step of determining the crossoverpoint.

In some embodiments the tissue shaping device includes a distal anchor,in which case the deploying step may include the step of anchoring thedistal anchor proximal to the crossover point, such as by expanding thedistal anchor through self-expansion or through the application of anactuation force. The anchoring force may be one-two pounds.

In some embodiments, the deploying step further includes the step ofapplying a proximally directed force on the distal anchor—in someembodiments from outside the patient—such as by moving the proximalanchor proximally. The tissue shaping device may further include aproximal anchor and a connector disposed between the distal anchor andthe proximal anchor, with the deploying step further including the stepof anchoring the proximal anchor (e.g., in the coronary sinus or atleast partially outside the coronary sinus), such as by expanding theproximal anchor through self-expansion or through the application of anactuation force. The step of anchoring the proximal anchor may beperformed before or after the step of applying a proximally directedforce on the distal anchor.

The deploying step of the method may include the step of deploying adistal anchor of the device from a distal end of a catheter. The methodmay also include the step of recapturing the distal anchor into acatheter and optionally redeploying the distal anchor. The deployingstep of the method may also include the step of deploying a proximalanchor of the device from a distal end of a catheter, and the mayinclude the step of recapturing the proximal anchor into a catheter andoptionally redeploying the distal anchor. The entire device may also berecaptured by a catheter and redeployed from the catheter.

The method may also include the step of selecting the tissue shapingdevice from a set of tissue shaping devices that includes tissue shapingdevices of a plurality of lengths and/or tissue shaping devices of aplurality of anchor sizes prior to the delivering step.

The invention is also a set of devices for use in treating mitral valveregurgitation, with the set including a plurality of tissue shapingdevices having different lengths, each of the tissue shaping devicesbeing configured to be deliverable to a coronary sinus of a patientwithin a catheter having an outer diameter no greater than nine or tenfrench. In some embodiments the tissue shaping devices each include ananchor (such as a distal anchor or a proximal anchor) having an expandedconfiguration and an unexpanded configuration for delivery via catheter.In some embodiments, at least one tissue shaping device in the set has alength 60 mm or less and at least one tissue shaping device in the sethas a length more than 60 mm. In some embodiments the distal anchor ofeach tissue shaping device in the set in its expanded configuration hasa diameter equal to or greater than a coronary sinus diameter at adistal anchor location (e.g., about 7 mm. to about 16 mm.), and theproximal anchor of each tissue shaping device in the set in its expandedconfiguration has a diameter equal to or greater than a coronary sinusdiameter at a proximal anchor location (e.g., about 9 mm. to about 20mm.) In some sets, the anchors are self-expanding, in other sets theanchors are actuatable, while still other sets have at least one devicewith a self-expanding anchor and one with an actuatable anchor. The setmay also include a catheter having an outer diameter no greater thannine to ten french.

Another aspect of the invention is a set of devices for use in treatingmitral valve regurgitation, with the set including a plurality of tissueshaping devices each with an anchor having an unexpanded configurationand an expanded configuration, the anchors having different diameterswhen in their expanded configurations, and each of the tissue shapingdevices being configured to be deliverable to a coronary sinus of apatient within a catheter having an outer diameter no greater than nineto ten french. In some embodiments the anchor is a distal anchor (suchas a self-expanding anchor or an actuatable anchor), and the devicesfurther include a proximal anchor (such as a self-expanding anchor or anactuatable anchor) having an unexpanded configuration and an expandedconfiguration, the proximal anchors having different diameters when intheir expanded configurations. In some embodiments the diameters of thedistal anchors of the tissue shaping devices in the set in theirexpanded configurations range from about 7 mm. to about 16 mm., and insome embodiments the diameters of the proximal anchors of the tissueshaping devices in the set in their expanded configurations range fromabout 9 mm. to about 20 mm. The set may also include a catheter havingan outer diameter no greater than nine to ten french.

The invention will be described in more detail below with reference tothe drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic view of a tissue shaping device according to apreferred embodiment as deployed within a coronary sinus.

FIG. 2 is a schematic view of a tissue shaping device according to analternative embodiment as deployed within a coronary sinus.

FIG. 3 is a schematic view of a tissue shaping device being delivered toa coronary sinus within a catheter.

FIG. 4 is a schematic view of a partially deployed tissue shaping devicewithin a coronary sinus.

FIG. 5 is a schematic view of a partially deployed and cinched tissueshaping device within a coronary sinus.

FIG. 6 is an elevational view of yet another embodiment of a tissueshaping device according to this invention.

FIG. 7 is a schematic drawing showing a method of determining thecrossover point between a circumflex artery and a coronary sinus.

FIG. 8 is a perspective drawing of a tissue shaping device according toone embodiment of this invention.

FIG. 9 is a partial sectional view of the tissue shaping device of FIG.8 in an unexpanded configuration within a catheter.

FIG. 10 is a perspective view of an anchor for use with a tissue shapingdevice according to this invention.

FIG. 11 is a perspective view of another anchor for use with a tissueshaping device according to this invention.

FIG. 12 is a perspective view of yet another anchor for use with atissue shaping device according to this invention.

FIG. 13 is a perspective view of still another anchor for use with atissue shaping device according to this invention.

FIG. 14 is a perspective view of another anchor for use with a tissueshaping device according to this invention.

FIG. 15 is a perspective view of yet another anchor for use with atissue shaping device according to this invention.

FIG. 16 is a perspective view of part of an anchor for use with a tissueshaping device according to this invention.

FIG. 17 is a perspective view of still another anchor for use with atissue shaping device according to this invention.

FIG. 18 is a perspective view of another anchor for use with a tissueshaping device according to this invention.

FIG. 19 is a perspective view of yet another anchor for use with atissue shaping. device according to this invention.

FIG. 20 is a perspective view of still another anchor for use with atissue shaping device according to this invention.

FIG. 21 is a perspective view of a tandem anchor for use with a tissueshaping device according to this invention.

FIG. 22 is a perspective view of a connector with integral anchor crimpsfor us in a tissue shaping device according to this invention.

FIG. 23 is a perspective view of a tissue shaping device employing theconnector of FIG. 22.

FIG. 24 is a perspective view of another connector for use with a tissueshaping device according to this invention.

FIG. 25 is a perspective view of yet another connector for use with atissue shaping device according to this invention.

FIG. 26 is a side view of a connector for use with a tissue shapingdevice according to this invention.

FIG. 27 is a side view of another connector for use with a tissueshaping device according to this invention.

FIG. 28 is a perspective view of yet another tissue shaping deviceaccording to this invention.

FIG. 29 is a side view of the tissue shaping device shown in FIG. 28.

FIG. 30 is a schematic view of another embodiment demonstrating themethod of this invention.

FIG. 31 is a schematic view of yet another embodiment demonstrating themethod of this invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a partial view of a human heart 10 and some surroundinganatomical structures. The main coronary venous vessel is the coronarysinus 12, defined as starting at the ostium 14 or opening to the rightatrium and extending through the great cardiac vein to the anteriorinterventricular (“AIV”) sulcus or groove 16. Also shown is the mitralvalve 20 surrounded by the mitral valve annulus 22 and adjacent to atleast a portion of the coronary sinus 12. The circumflex artery 24 shownin FIG. 1 passes between the coronary sinus 12 and the heart. Therelative size and location of each of these structures vary from personto person.

Disposed within the coronary sinus 12 is a tissue shaping device 30. Asshown in FIG. 1, the distal end 32 of device 30 is disposed proximal tocircumflex artery 24 to reshape the adjacent mitral valve annulus 22 andthereby reduce mitral valve regurgitation. As shown in FIG. 1, device 30has a distal anchor 34, a proximal anchor 36 and a connector 38.

In the embodiment of FIG. 1, proximal anchor 36 is deployed completelywithin the coronary sinus. In the alternative embodiment shown in FIG.2, proximal anchor is deployed at least partially outside the coronarysinus.

FIGS. 3-6 show a method according to this invention. As shown in FIG. 3,a catheter 50 is maneuvered in a manner known in the art through theostium 14 into coronary sinus 12. In order to be navigable through thepatient's venous system, catheter 50 preferably has an outer diameter nogreater than ten french, most preferably with an outer diameter no morethan nine french. Disposed within catheter 50 is device 30 in anunexpanded configuration, and extending back through catheter 50 fromdevice 30 to the exterior of the patient is a tether or control wire 52.In some embodiments, control wire 52 may include multiple tether andcontrol wire elements, such as those described in U.S. patentapplication Ser. No. 10/331,143.

According to one preferred embodiment, the device is deployed as fardistally as possible without applying substantial compressive force onthe circumflex or other major coronary artery. Thus, the distal end ofcatheter 50 is disposed at a distal anchor location proximal of thecrossover point between the circumflex artery 24 and the coronary sinus12 as shown in FIG. 3. At this point, catheter 50 is withdrawnproximally while device 30 is held stationary by control wire 52 touncover distal anchor 34 at the distal anchor location within coronarysinus 12. Alternatively, the catheter may be held stationary whiledevice 30 is advanced distally to uncover the distal anchor.

Distal anchor 34 is either a self-expanding anchor or an actuatableanchor or a combination self-expanding and actuatable anchor. Onceuncovered, distal anchor 34 self-expands, or is expanded through theapplication of an actuation force (such as a force transmitted throughcontrol wire 52), to engage the inner wall of coronary sinus 12, asshown in FIG. 4. The distal anchor's anchoring force, i.e., the forcewith which the distal anchor resists moving in response to aproximally-directed force, must be sufficient not only to maintain thedevice's position within the coronary sinus but also to enable thedevice to be used to reshape adjacent tissue in a manner such as thatdescribed below. In a preferred embodiment, distal anchor 34 engages thecoronary sinus wall to provide an anchoring force of at least one pound,most preferably an anchoring force of at least two pounds. The anchor'sexpansion energy to supply the anchoring force comes from strain energystored in the anchor due to its compression for catheter delivery, froman actuation force, or a combination of both, depending on anchordesign.

While device 30 is held in place by the anchoring force of distal anchor34, catheter 50 is withdrawn further proximally to a point just distalof proximal anchor 36, as shown in FIG. 5. A proximally directed forceis then exerted on distal anchor 34 by control wire 52 through connector38. In this embodiment, the distance between the distal and proximalanchors along the connector is fixed, so the proximally directed forcemoves proximal anchor 36 proximally with respect to the coronary sinuswhile distal anchor 34 remains stationary with respect to the coronarysinus. This cinching action straightens that section of coronary sinus12, thereby modifying its shape and the shape of the adjacent mitralvalve 20, moving the mitral valve leaflets into greater coaptation andreducing mitral valve regurgitation. In some embodiments of theinvention, the proximal anchor is moved proximally about 1-6 cm., mostpreferably at least 2 cm., in response to the proximally directed force.In other embodiments, such as embodiments in which the distance betweenthe distal and proximal anchors is not fixed (e.g., where the connectorlength is variable), the proximal anchor may stay substantiallystationary with respect to the coronary sinus despite the application ofa proximally directed force on the distal anchor.

After the appropriate amount of reduction in mitral valve regurgitationhas been achieved (as determined, e.g., by viewing doppler-enhancedechocardiograms), the proximal anchor is deployed. Other patient vitalsigns, such as cardiac perfusion, may also be monitored during thisprocedure as described in U.S. patent application Ser. No. 10/366,585.

In preferred embodiments, the proximal anchor's anchoring force, i.e.,the force with which the proximal anchor resists moving in response to adistally-directed force, must be sufficient not only to maintain thedevice's position within the coronary sinus but also to enable thedevice to maintain the adjacent tissue's cinched shape. In a preferredembodiment, the proximal anchor engages the coronary sinus wall toprovide an anchoring force of at least one pound, most preferably ananchoring force of at least two pounds. As with the distal anchor, theproximal anchor's expansion energy to supply the anchoring force comesfrom strain energy stored in the anchor due to its compression forcatheter delivery, from an actuation force, or a combination of both,depending on anchor design.

In a preferred embodiment, the proximal anchor is deployed bywithdrawing catheter 50 proximally to uncover proximal anchor 36, theneither permitting proximal anchor 36 to self-expand, applying anactuation force to expand the anchor, or a combination of both. Thecontrol wire 52 is then detached, and catheter 50 is removed from thepatient. The device location and configuration as deployed according tothis method is as shown in FIG. 1.

Alternatively, proximal anchor 36 may be deployed at least partiallyoutside of the coronary sinus after cinching to modify the shape of themitral valve tissue, as shown in FIG. 2. In both embodiments, becausedistal anchor 34 is disposed proximal to the crossover point betweencoronary sinus 12 and circumflex artery 24, all of the anchoring andtissue reshaping force applied to the coronary sinus by device 30 issolely proximal to the crossover point.

In alternative embodiments, the proximal anchor may be deployed prior tothe application of the proximally directed force to cinch the device toreshape the mitral valve tissue. One example of a device according tothis embodiment is shown in FIG. 6. Device 60 includes a self-expandingdistal anchor 62, a self-expanding proximal anchor 64 and a connector66. The design of distal anchor 62 enables it to maintain its anchoringforce when a proximally directed force is applied on it to cinch, whilethe design of proximal anchor 64 permits it to be moved proximally afterdeployment while resisting distal movement after cinching. Cinchingafter proximal anchor deployment is described in more detail in U.S.patent application Ser. No. 10/066,426, filed Jan. 30, 2002, thedisclosure of which is incorporated herein by reference. In thisembodiment as well, distal anchor 62 is disposed proximal to thecrossover point between coronary sinus 12 and circumflex artery 24 sothat all of anchoring and tissue reshaping force applied to the coronarysinus by device 30 is solely proximal to the crossover point.

It may be desirable to move and/or remove the tissue shaping deviceafter deployment or to re-cinch after initial cinching. According tocertain embodiments of the invention, therefore, the device or one ofits anchors may be recaptured. For example, in the embodiment of FIG. 1,after deployment of proximal anchor 36 but prior to disengagement ofcontrol wire 52, catheter 50 may be moved distally to place proximalanchor 36 back inside catheter 50, e.g., to the configuration shown inFIG. 5. From this position, the cinching force along connector 38 may beincreased or decreased, and proximal anchor 36 may then be redeployed.

Alternatively, catheter 50 may be advanced distally to recapture bothproximal anchor 36 and distal anchor 34, e.g., to the configurationshown in FIG. 3. From this position, distal anchor 34 may be redeployed,a cinching force applied, and proximal anchor 36 deployed as discussedabove. Also from this position, device 30 may be removed from thepatient entirely by simply withdrawing the catheter from the patient.

Fluoroscopy (e.g., angiograms and venograms) may be used to determinethe relative positions of the coronary sinus and the coronary arteriessuch as the circumflex artery, including the crossover point between thevessels and whether or not the artery is between the coronary sinus andthe heart. Radiopaque dye may be injected into the coronary sinus andinto the arteries in a known manner while the heart is viewed on afluoroscope.

An alternative method of determining the relative positions of thevessels is shown in FIG. 7. In this method, guide wires 70 and 72 areinserted into the coronary sinus 12 and into the circumflex artery 24 orother coronary artery, and the relative positions of the guide wires areviewed on a fluoroscope to identify the crossover point 74.

FIG. 8 illustrates one embodiment of a tissue shaping device inaccordance with the present invention. The tissue shaping device 100includes a connector or support wire 102 having a proximal end 104 and adistal end 106. The support wire 102 is made of a biocompatible materialsuch as stainless steel or a shape memory material such as nitinol wire.

In one embodiment of the invention, connector 102 comprises a doublelength of nitinol wire that has both ends positioned within a distalcrimp tube 108. Proximal to the proximal end of the crimp tube 108 is adistal lock bump 110 that is formed by the support wire bending awayfrom the longitudinal axis of the support 102 and then being bentparallel to the longitudinal axis of the support before being bent againtowards the longitudinal axis of the support to form one half 110 a ofdistal lock bump 110. From distal lock bump 110, the wire continuesproximally through a proximal crimp tube 112. On exiting the proximalend of the proximal crimp tube 112, the wire is bent to form anarrowhead-shaped proximal lock bump 114. The wire of the support 102then returns distally through the proximal crimp tube 112 to a positionjust proximal to the proximal end of the distal crimp tube 108 whereinthe wire is bent to form a second half 110 b of the distal lock 110.

At the distal end of connector 102 is an actuatable distal anchor 120that is formed of a flexible wire such as nitinol or some other shapememory material. As shown in FIG. 8, the wire forming the distal anchorhas one end positioned within the distal crimp tube 108. After exitingthe distal end of the crimp tube 108, the wire forms a figure eightconfiguration whereby it bends upward and radially outward from thelongitudinal axis of the crimp tube 108. The wire then bends backproximally and crosses the longitudinal axis of the crimp tube 108 toform one leg of the figure eight. The wire is then bent to form a doubleloop eyelet or loop 122 around the longitudinal axis of the support wire102 before extending radially outwards and distally back over thelongitudinal axis of the crimp tube 108 to form the other leg of thefigure eight. Finally, the wire is bent proximally into the distal endof the crimp tube 108 to complete the distal anchor 120.

The distal anchor is expanded by using a catheter or locking tool toexert an actuation force sliding eyelet 122 of the distal anchor from aposition that is proximal to distal lock bump 110 on the connector to aposition that is distal to distal lock bump 110. The bent-out portions110 a and 110 b of connector 110 are spaced wider than the width ofeyelet 122 and provide camming surfaces for the locking action. Distalmovement of eyelet 122 pushes these camming surfaces inward to permiteyelet 122 to pass distally of the lock bump 110, then return to theiroriginal spacing to keep eyelet 122 in the locked position.

Actuatable proximal anchor 140 is formed and actuated in a similarmanner by moving eyelet 142 over lock bump 114. Both the distal and theproximal anchor provide anchoring forces of at least one pound, and mostpreferably two pounds.

FIG. 9 illustrates one method for delivering a tissue shaping device 100in accordance with the present invention to a desired location in thebody, such as the coronary sinus to treat mitral valve regurgitation. Asindicated above, device 100 is preferably loaded into and routed to adesired location within a catheter 200 with the proximal and distalanchors in an unexpanded or deformed condition. That is, eyelet 122 ofdistal anchor 120 is positioned proximal to the distal lock bump 110 andthe eyelet 142 of the proximal anchor 140 is positioned proximal to theproximal lock bump 114. The physician ejects the distal end of thedevice from the catheter 200 into the coronary sinus by advancing thedevice or retracting the catheter or a combination thereof. A pusher(not shown) provides distal movement of the device with respect tocatheter 200, and a tether 201 provides proximal movement of the devicewith respect to catheter 200.

Because of the inherent elasticity of the material from which it isformed, the distal anchor begins to expand as soon as it is outside thecatheter. Once the device is properly positioned, catheter 200 isadvanced to place an actuation force on distal anchor eyelet 122 to pushit distally over the distal lock bump 110 so that the distal anchor 120further expands and locks in place to securely engage the wall of thecoronary sinus. Next, a proximally-directed force is applied toconnector 102 and distal anchor 120 via a tether or control wire 201extending through catheter outside the patient to apply sufficientpressure on the tissue adjacent the connector to modify the shape ofthat tissue. In the case of the mitral valve, fluoroscopy, ultrasound orother imaging technology may be used to see when the device suppliessufficient pressure on the mitral valve to aid in its complete closurewith each ventricular contraction without otherwise adversely affectingthe patient.

The proximally directed reshaping force causes the proximal anchor 140to move proximally. In one embodiment, for example, proximal anchor 140can be moved about 1-6 cm., most preferably at least 2 cm., proximallyto reshape the mitral valve tissue. The proximal anchor 140 is thendeployed from the catheter and allowed to begin its expansion. Thelocking tool applies an actuation force on proximal anchor eyelet 142 toadvance it distally over the proximal lock bump 114 to expand and lockthe proximal anchor, thereby securely engaging the coronary sinus wallto maintain the proximal anchor's position and to maintain the reshapingpressure of the connector against the coronary sinus wall.Alternatively, catheter 200 may be advanced to lock proximal anchor 140.

Finally, the mechanism for securing the proximal end of the device canbe released. In one embodiment, the securement is made with a braidedloop 202 at the end of tether 201 and a lock wire 204. The lock wire 204is withdrawn thereby releasing the loop 202 so it can be pulled throughthe proximal lock bump 114 at the proximal end of device 100.

Reduction in mitral valve regurgitation using devices of this inventioncan be maximized by deploying the distal anchor as far distally in thecoronary sinus as possible. In some instances it may be desirable toimplant a shorter tissue shaping device, such as situations where thepatient's circumflex artery crosses the coronary sinus relatively closerto the ostium or situations in which the coronary sinus itself isshorter than normal. As can be seen from FIG. 9, anchor 120 in itsunexpanded configuration extends proximally along connector 102 withincatheter 200. Making the device shorter by simply shortening theconnector, however, may cause the eyelet 122 and proximal portion of thedistal anchor 120 to overlap with portions of the proximal anchor whenthe device is loaded into a catheter, thereby requiring the catheterdiameter to be larger than is needed for longer versions of the device.For mitral valve regurgitation applications, a preferred catheterdiameter is ten french or less (most preferably nine french), and thetissue shaping device in its unexpanded configuration must fit withinthe catheter.

FIGS. 10-23 show embodiments of the device of this invention havingflexible and expandable wire anchors which permit the delivery of tissueshaping devices 60 mm or less in length by a ten french (or less)catheter. In some embodiments, one or both of the anchors are providedwith bending points about which the anchors deform when placed in theirunexpanded configuration for delivery by a catheter or recapture into acatheter. These bending points enable the anchors to deform intoconfigurations that minimize overlap with other elements of the device.In other embodiments, the distal anchor is self-expanding, therebyavoiding the need for a proximally-extending eyelet in the anchor'sunexpanded configuration that might overlap with the unexpanded proximalanchor within the delivery and/or recapture catheter.

FIG. 10 shows an actuatable anchor design suitable for a shorter tissueshaping device similar to the device shown in FIGS. 8 and 9. In thisembodiment, distal anchor 300 is disposed distal to a connector 302. Asin the embodiment of FIG. 8, anchor 300 is formed in a figure eightconfiguration from flexible wire such as nitinol held by a crimp tube304. An eyelet 306 is formed around the longitudinal axis of connector302. A distally directed actuation force on eyelet 306 moves it over alock bump 308 formed in connector 302 to actuate and lock anchor 300.

FIG. 10 shows anchor 300 in an expanded configuration. In an unexpandedconfiguration, such as a configuration suitable for loading anchor 300and the rest of the tissue shaping device into a catheter for initialdeployment to treat mitral valve regurgitation, eyelet 306 is disposedproximal to lock bump 308, and the figure eight loops of anchor 300 arecompressed against crimp 304. In order to limit the proximal distanceeyelet 306 must be moved along the connector to compress anchor 300 intoan unexpanded configuration, bending points 310 are formed in the distalstruts of anchor 300. Bending points 310 are essentially kinks, i.e.,points of increased curvature, formed in the wire. When anchor 300 iscompressed into an unexpanded configuration, bending points 310 deformsuch that the upper arms 312 of the distal struts bend around bendingpoints 310 and move toward the lower arms 314 of the distal struts,thereby limiting the distance eyelet 306 and the anchor's proximalstruts must be moved proximally along the connector to compress theanchor.

Likewise, if distal anchor were to be recaptured into a catheter forredeployment or removal from the patient, anchor 300 would deform aboutbending points 310 to limit the cross-sectional profile of the anchorwithin the catheter, even if eyelet 306 were not moved proximally overlock bump 308 during the recapture procedure. Bending points may also beprovided on the proximal anchor in a similar fashion.

As stated above, distal anchor 300 may be part of a tissue shapingdevice (such as that shown in FIGS. 8 and 9) having a proximal anchorand a connector disposed between the anchors. To treat mitral valveregurgitation, distal anchor 300 may be deployed from a catheter andexpanded with an actuation force to anchor against the coronary sinuswall to provide an anchoring force of at least one pound, preferably atleast two pounds, and to lock anchor 300 in an expanded configuration. Aproximally directed force is applied to distal anchor 300 throughconnector 302, such as by moving the proximal anchor proximally about1-6 cm., more preferably at least 2 cm., by pulling on a tether orcontrol wire operated from outside the patient. The proximal anchor maythen be deployed to maintain the reshaping force of the device.

One aspect of anchor 300 is its ability to conform and adapt to avariety of vessel sizes. For example, when anchor 300 is expanded insidea vessel such as the coronary sinus, the anchor's wire arms may contactthe coronary sinus wall before the eyelet 306 has been advanced distallyover lock bump 308 to lock the anchor in place. While continued distaladvancement of eyelet 306 will create some outward force on the coronarysinus wall, much of the energy put into the anchor by the anchoractuation force will be absorbed by the deformation of the distal strutsabout bending points 310, which serve as expansion energy absorptionelements and thereby limit the radially outward force on the coronarysinus wall. This feature enables the anchor to be used in a wider rangeof vessel sizes while reducing the risk of over-expanding the vessel.

FIG. 11 shows another anchor design suitable for a shorter tissueshaping device similar to the device shown in FIGS. 8 and 9. In thisembodiment, distal anchor 320 is disposed distal to a connector 322. Asin the embodiment of FIG. 8, anchor 320 is formed in a figure eightconfiguration from flexible wire such as nitinol held by a crimp tube324. Unlike the embodiment of FIG. 10, however, anchor 320 isself-expanding and is not actuatable. Eyelet 326 is held in place by asecond crimp 325 to limit or eliminate movement of the anchor's proximalconnection point proximally or distally, e.g., along connector 322.

FIG. 11 shows anchor 320 in an expanded configuration. In an unexpandedconfiguration, such as a configuration suitable for loading anchor 320and the rest of the tissue shaping device into a catheter for initialdeployment to treat mitral valve regurgitation, the figure eight loopsof anchor 320 are compressed. Bending points 330 are formed in thedistal struts of anchor 320. When anchor 320 is compressed into anunexpanded configuration, bending points 330 deform such that the upperarms 332 of the distal struts bend around bending points 330 and movetoward the lower arms 334 of the distal struts. Depending upon the exactlocation of bending points 330, very little or none of the wire portionof anchor 320 is disposed proximally along crimp 325 or connector 322when anchor 320 is in its unexpanded configuration.

Likewise, if distal anchor were to be recaptured into a catheter forredeployment or removal from the patient, anchor 320 would deform aboutbending points 330 to limit the cross-sectional profile of the anchorwithin the catheter. Bending points may also be provided on the proximalanchor in a similar fashion.

Distal anchor 320 may be part of a tissue shaping device (such as thatshown in FIGS. 8 and 9) having a proximal anchor and a connectordisposed between the anchors. Due to the superelastic properties of itsshape memory material, distal anchor 320 may be deployed from a catheterto self-expand to anchor against the coronary sinus wall to provide ananchoring force of at least one pound, preferably at least two pounds. Aproximally directed force may then be applied to distal anchor 320through connector 322, such as by moving the proximal anchor proximallyabout 1-6 cm., more preferably at least 2 cm., by pulling on a tether orcontrol wire operated from outside the patient. The proximal anchor maythen be deployed to maintain the reshaping force of the device.

FIG. 12 shows another embodiment of an anchor suitable for use in ashorter tissue shaping device. In this embodiment, distal anchor 340 isdisposed distal to a connector 342. As in the embodiment of FIG. 11,anchor 340 is formed in a figure eight configuration from flexible wiresuch as nitinol held by a crimp tube 344. Also like that embodiment,anchor 340 is self-expanding and is not actuatable. The loop of anchor340 forming the anchor's proximal struts passes through a loop 346extending distally from a second crimp 345 to limit or eliminatemovement of the anchor's proximal struts proximally or distally, e.g.,along connector 342.

FIG. 12 shows anchor 340 in an expanded configuration. Like the deviceof FIG. 11, in an unexpanded configuration, such as a configurationsuitable for loading anchor 340 and the rest of the tissue shapingdevice into a catheter for initial deployment to treat mitral valveregurgitation, the figure eight loops of anchor 340 are compressed.Unlike the FIG. 11 embodiment, however, bending points 350 are formed inthe proximal struts of anchor 340. When anchor 340 is compressed into anunexpanded configuration, bending points 350 deform such that the upperarms 352 of the distal struts bend around bending points 350 and movetoward the lower arms 354 of the distal struts. The amount of the wireportion of anchor 340 extending proximally along crimp 345 and connector342 in its unexpanded configuration depends on the location of bendingpoints 350. In one embodiment, the bending points are formed at thetallest and widest part of the proximal struts.

Distal anchor 340 may be part of a tissue shaping device (such as thatshown in FIGS. 8 and 9) having a proximal anchor and a connectordisposed between the anchors. Due to the superelastic properties of itsshape memory material, distal anchor 340 may be deployed from a catheterto self-expand to anchor against the coronary sinus wall to provide ananchoring force of at least one pound, preferably at least two pounds. Aproximally directed force may then be applied to distal anchor 340through connector 342, such as by moving the proximal anchor proximallyabout 1-6 cm., more preferably at least 2 cm., by pulling on a tether orcontrol wire operated from outside the patient. The proximal anchor maythen be deployed to maintain the reshaping force of the device.

Bending points 350 also add to the anchoring force of distal anchor 340,e.g., by causing the anchor height to increase as the proximal strutsbecome more perpendicular to the connector in response to a proximallydirected force, thereby increasing the anchoring force. In the samemanner, bending points may be added to the distal struts of a proximalanchor to increase the proximal anchor's anchoring force in response toa distally directed force.

FIG. 13 shows yet another embodiment of an anchor suitable for use in ashorter tissue shaping device. In this embodiment, distal anchor 360 isdisposed distal to a connector 362. As in the embodiment of FIG. 12,anchor 360 is formed in a figure eight configuration from flexible wiresuch as nitinol held by a crimp tube 364. Also like that embodiment,anchor 360 is self-expanding and is not actuatable. The loop of anchor360 forming the anchor's proximal struts passes through a loop 366extending distally from a second crimp 365 to limit or eliminatemovement of the anchor's proximal struts proximally or distally, e.g.,along connector 362.

FIG. 13 shows anchor 360 in an expanded configuration. Like the deviceof FIG. 12, in an unexpanded configuration, such as a configurationsuitable for loading anchor 360 and the rest of the tissue shapingdevice into a catheter for initial deployment to treat mitral valveregurgitation, the figure eight loops of anchor 360 are compressed.Unlike the FIG. 12 embodiment, however, bending points 370 are formed inboth the proximal struts and the distal struts of anchor 360.

Anchor 360 may be used as part of a tissue shaping device like theembodiments discussed above.

FIG. 14 shows an actuatable anchor design-suitable for a shorter tissueshaping device similar to the device shown in FIGS. 8 and 9. In thisembodiment, distal anchor 380 is disposed distal to a connector 382. Asin the other embodiments, anchor 380 is formed in a figure eightconfiguration from flexible wire such as nitinol held by a crimp tube384. In contrast to the embodiment of FIG. 10, eyelets 386 and 387 areformed in each of the anchor's proximal struts around the longitudinalaxis of connector 382. This arrangement reduces the radially outwardforce of the anchor. A distally directed actuation force on eyelets 386and 387 move them over a lock bump 388 formed in connector 382 toactuate and lock anchor 380.

FIG. 14 shows anchor 380 in an expanded configuration. In an unexpandedconfiguration, such as a configuration suitable for loading anchor 380and the rest of the tissue shaping device into a catheter for initialdeployment to treat mitral valve regurgitation, eyelets 386 and 387 aredisposed proximal to lock bump 388 and the figure eight loops of anchor380 are compressed against crimp 384. In order to limit the proximaldistance eyelets 386 and 387 must be moved to compress anchor 380 intoan unexpanded configuration, bending points 390 are formed in the distalstruts of anchor 380. When anchor 380 is compressed into an unexpandedconfiguration, bending points 390 deform such that the upper arms 392 ofthe distal struts bend around bending points 390 and move toward thelower arms 394 of the distal struts, thereby limiting the distanceeyelets 386 and 387 and the anchor's proximal struts must be movedproximally along the connector to compress the anchor.

If distal anchor were to be recaptured into a catheter for redeploymentor removal from the patient, anchor 380 would deform about bendingpoints 390 to limit the cross-sectional profile of the anchor within thecatheter, even if eyelets 386 and 387 were not moved proximally overlock bump 388 during the recapture procedure. Bending points may also beprovided on the proximal anchor in a similar fashion.

As with the other embodiments above, distal anchor 380 may be part of atissue shaping device (such as that shown in FIGS. 8 and 9) having aproximal anchor and a connector disposed between the anchors. To treatmitral valve regurgitation, distal anchor 380 may be deployed from acatheter and expanded with an actuation force to anchor against thecoronary sinus wall to provide an anchoring force of at least one pound,preferably at least two pounds, and to lock anchor 380 in an expandedconfiguration. A proximally directed force is applied to distal anchor380 through connector 382, such as by moving the proximal anchorproximally about 1-6 cm., more preferably at least 2 cm., by pulling ona tether or control wire operated from outside the patient. The proximalanchor may then be deployed to maintain the reshaping force of thedevice.

As with other embodiments, one aspect of anchor 380 is its ability toconform and adapt to a variety of vessel sizes. For example, when anchor380 is expanded inside a vessel such as the coronary sinus, the anchor'swire arms may contact the coronary sinus wall before the eyelets 386 and387 have been advance distally over lock bump 388 to lock the anchor inplace. While continued distal advancement of eyelet 386 will create someoutward force on the coronary sinus wall, much of the energy put intothe anchor by the anchor actuation force will be absorbed by thedeformation of the distal struts about bending points 390.

FIG. 15 shows yet another embodiment of an actuatable anchor for use ina shorter tissue shaping device. Proximal anchor 400 is disposedproximal to a connector 402. As in other embodiments, anchor 400 isformed in a figure eight configuration from flexible wire such asnitinol held by a crimp tube 404. An eyelet 406 is formed around a lockbump 408 extending proximally from crimp 404. A distally directedactuation force on eyelet 406 moves it over lock bump 408 to actuate andlock anchor 400.

FIG. 15 shows anchor 400 in an expanded configuration. When anchor 400is compressed into an unexpanded configuration, bending points 410formed as loops in the anchor wire deform such that the upper arms 412of the distal struts bend around bending points 410 and move toward thelower arms 414 of the distal struts. As with the other embodiments,proximal anchor 400 may be part of a tissue shaping device (such as thatshown in FIGS. 8 and 9) having a distal anchor and a connector disposedbetween the anchors.

Like other embodiments, one aspect of anchor 400 is its ability toconform and adapt to a variety of vessel sizes. For example, when anchor400 is expanded inside a vessel such as the coronary sinus, the anchor'swire arms may contact the coronary sinus wall before the eyelet 406 hasbeen advanced distally over lock bump 408 to lock the anchor in place.While continued distal advancement of eyelet 406 will create someoutward force on the coronary sinus wall, much of the energy put intothe anchor by the anchor actuation force will be absorbed by thedeformation of the distal struts about bending points 410, which serveas expansion energy absorption elements and thereby limit the radiallyoutward force on the coronary sinus wall.

In other embodiments, the looped bending points of the FIG. 15embodiment may be formed on the anchor's proximal struts in addition toor instead of on the distal struts. The looped bending point embodimentmay also be used in a distal anchor, as shown in FIG. 16 (without thecrimp or connector). Note that in the embodiment of FIG. 16 the proximaland distal struts of anchor 420 as well as the eyelet 422 and bendingpoints 424 are formed from a single wire.

FIG. 17 shows an embodiment of a distal anchor 440 similar to that ofFIG. 10 suitable for use in a shorter tissue shaping device. In thisembodiment, however, extra twists 442 are added at the apex of theanchor's figure eight pattern. As in the FIG. 10 embodiment, bendingpoints 444 are formed in the anchor's distal struts. As shown, anchor440 is actuatable by moving eyelet 446 distally over a lock bump 448formed in connector 450. Anchor 440 may also be made as a self-expandinganchor by limiting or eliminating movement of the proximal struts ofanchor 440 along connector 450, as in the embodiment shown in FIG. 11.As with other embodiments, the bending points help anchor 440 adapt andconform to different vessel sizes. In addition, the extra twists 442also help the anchor adapt to different vessel diameters by keeping theanchor's apex together.

As in the other embodiments, anchor 440 is preferably formed fromnitinol wire. Anchor 440 may be used as part of a tissue shaping devicein a manner similar to the anchor of FIG. 10 (for the actuatable anchorembodiment) or the anchor of FIG. 11 (for the self-expanding anchorembodiment). Anchor 440 may also be used as a proximal anchor.

FIG. 18 shows an embodiment of a distal anchor 460 similar to that ofFIG. 17. In this embodiment, however, the bending points 462 are formedin the anchor's proximal struts, as in the self-expanding anchor shownin FIG. 12. As in the FIG. 17 embodiment, extra twists 464 are added atthe apex of the anchor's figure eight pattern. As shown, anchor 460 isactuatable by moving eyelet 466 distally over a lock bump 468 formed inconnector 470. Anchor 460 may also be made as a self-expanding anchor bylimiting or eliminating movement of the proximal connection point ofanchor 460 along connector 470, as in the embodiment shown in FIG. 11.As with the embodiment of FIG. 17, the bending points help anchor 460adapt and conform to different vessel sizes. In addition, the extratwists 464 also help the anchor adapt to different vessel diameters bykeeping the anchor's apex together.

As in the other embodiments, anchor 460 is preferably formed fromnitinol wire. Anchor 460 may be used as part of a tissue shaping devicein a manner similar to the anchor of FIG. 10 (for the actuatable anchorembodiment) or the anchor of FIG. 11 (for the self-expanding anchorembodiment). Anchor 460 may also be used as a proximal anchor.

FIG. 19 shows an embodiment of a self-expanding distal anchor 480suitable for use in a shorter tissue shaping device. As in the otherembodiments, anchor 480 is formed in a figure eight configuration fromflexible wire such as nitinol held by a crimp tube 482. The base of thefigure eight pattern is narrower in this embodiment, however, with theanchor's proximal struts 484 passing through crimp 482.

Distal anchor 480 may be part of a tissue shaping device (such as thatshown in FIGS. 8 and 9) having a proximal anchor and a connectordisposed between the anchors. To treat mitral valve regurgitation,distal anchor 480 may be deployed from a catheter and allowed toself-expand to anchor against the coronary sinus wall to provide ananchoring force of at least one pound, preferably at least two pounds. Aproximally directed force is applied to distal anchor 480 throughconnector 486, such as by moving the proximal anchor proximally about1-6 cm., more preferably at least 2 cm., by pulling on a tether orcontrol wire operated from outside the patient. The proximal anchor maythen be deployed to maintain the reshaping force of the device.

FIG. 20 shows an embodiment of a distal anchor suitable for use in ashorter tissue shaping device and similar to that of FIG. 10. In thisembodiment, distal anchor 500 is disposed distal to a connector 502. Asin other embodiments, anchor 500 is formed in a figure eightconfiguration from flexible wire such as nitinol held by a crimp tube504. An eyelet 506 is formed around the longitudinal axis of connector502. A distally directed actuation force on eyelet 506 moves it over alock bump 508 formed in connector 502 to actuate and lock anchor 500.

The angle of proximal struts 501 and the angle of distal struts 503 arewider than corresponding angles in the FIG. 10 embodiment, however,causing anchor 500 to distend more in width than in height whenexpanded, as shown. In an unexpanded configuration, such as aconfiguration suitable for loading anchor 500 and the rest of the tissueshaping device into a catheter for initial deployment to treat mitralvalve regurgitation, eyelet 506 is disposed proximal to lock bump 508and the figure eight loops of anchor 500 are compressed against crimp504. In order to limit the proximal distance eyelet 506 must be movedalong the connector to compress anchor 500 into an unexpandedconfiguration, bending points 510 are formed in the distal struts 503,as in the FIG. 10 embodiment, to limit the width of the device in itsunexpanded configuration within a catheter.

Distal anchor 500 may be part of a tissue shaping device (such as thatshown in FIGS. 8 and 9) having a proximal anchor and a connectordisposed between the anchors. To treat mitral valve regurgitation,distal anchor 500 may be deployed from a catheter and expanded with anactuation force to anchor against the coronary sinus wall to provide ananchoring force of at least one pound, preferably at least two pounds,and to lock anchor 500 in an expanded configuration. A proximallydirected force is applied to distal anchor 500 through connector 502,such as by moving the proximal anchor proximally about 1-6 cm., morepreferably at least 2 cm., by pulling on a tether or control wireoperated from outside the patient. The proximal anchor may then bedeployed to maintain the reshaping force of the device.

The anchor shown in FIG. 20 may be used as a proximal anchor. Thisanchor may also be formed as a self-expanding anchor.

FIG. 21 shows a tandem distal anchor according to another embodiment ofthis invention. Self-expanding anchor 520 is formed in a figure eightconfiguration from flexible wire such as nitinol held by a crimp tube522. Eyelet 524 is held in place by the distal end of actuatable anchor540 to limit or eliminate proximal and distal movement of the proximalstruts of anchor 520. As in the anchor shown in FIG. 11, bending points530 are formed in the distal struts of anchor 520. Depending upon theexact location of bending points 530, very little or none of the wireportion of anchor 520 is disposed proximal to the distal end of anchor540 when anchor 520 is in its unexpanded configuration.

Likewise, if distal anchor were to be recaptured into a catheter forredeployment or removal from the patient, anchor 520 would deform aboutbending points 530 to limit the cross-sectional profile of the anchorwithin the catheter. Bending points may also be provided on the proximalanchor in a similar fashion.

Anchor 540 is similar to anchor 120 shown in FIG. 8. Anchor 540 isformed in a figure eight configuration from flexible wire such asnitinol held by a crimp tube 544. An eyelet 546 is formed around thelongitudinal axis of connector 542. A distally directed actuation forceon eyelet 546 moves it over a lock bump 548 formed in connector 542 toactuate and lock anchor 540.

Tandem anchors 520 and 540 may be part of a tissue shaping device (suchas that shown in FIGS. 8 and 9) having a proximal anchor and a connectordisposed between the anchors. Anchors 520 and 540 may be made from asingle wire or from separate pieces of wire. To treat mitral valveregurgitation, distal anchors 520 and 540 may be deployed from acatheter. Self-expanding anchor 520 will then self-expand, andactuatable anchor 540 may be expanded and locked with an actuationforce, to anchor both anchors against the coronary sinus wall to providean anchoring force of at least one pound, preferably at least twopounds. A proximally directed force is applied to anchors 520 and 540through connector 542, such as by moving the proximal anchor proximallyabout 1-6 cm., more preferably at least 2 cm., by pulling on a tether orcontrol wire operated from outside the patient. The proximal anchor maythen be deployed to maintain the reshaping force of the device.

While the anchor designs above were described as part of shorter tissueshaping devices, these anchors may be used in tissue shaping devices ofany length.

FIGS. 22 and 23 show an alternative embodiment in which the device'sconnector 560 is made integral with the distal and proximal crimp tubes562 and 564. In this embodiment, connector 560 is formed by cutting awaya section of a blank such as a nitinol (or other suitable material suchas stainless steel) cylinder or tube, leaving crimp tube portions 562and 564 intact. The radius of the semi-circular cross-section connectoris therefore the same as the radii of the two anchor crimp tubes.

Other connector shapes are possible for an integral connector and crimpdesign, of course. For example, the device may be formed from a blankshaped as a flat ribbon or sheet by removing rectangular edge sectionsfrom a central section, creating an I-shaped sheet (e.g., nitinol orstainless steel) having greater widths at the ends and a narrower widthin the center connector portion. The ends can then be rolled to form thecrimp tubes, leaving the connector substantially flat. In addition, inalternative embodiments, the connector can be made integral with justone of the anchors.

As shown in FIG. 23, a distal anchor 566 is formed in a figure eightconfiguration from flexible wire such as nitinol. Distal anchor 566 isself-expanding, and its proximal struts 568 are held in place by crimptube 562. Optional bending points may be formed in the proximal struts568 or distal struts 570 of anchor 566.

A proximal anchor 572 is also formed in a figure eight configurationfrom flexible wire such as nitinol with an eyelet 574 on its proximalend. A distally directed actuation force on eyelet 574 moves it over alock bump 576 extending proximally from crimp tube 564 to actuate andlock anchor 572. Lock bump 576 also serves as the connection point for atether or control wire to deploy and actuate device in the mannerdescribed above with respect to FIGS. 8 and 9. Optional bending pointsmay be formed in the proximal or distal struts of anchor 572.

When deployed in the coronary sinus to treat mitral valve regurgitation,the tissue shaping devices of this invention are subjected to cyclicbending and tensile loading as the patient's heart beats. FIG. 24 showsan alternative connector for use with the tissue shaping devices of thisinvention that distributes over more of the device any strain caused bythe beat to beat bending and tensile loading.

Connector 600 has a proximal anchor area 602, a distal anchor area 604and a central area 606. The distal anchor area may be longer than thedistal anchor attached to it, and the proximal anchor area may be longerthan the proximal anchor attached to it. An optional lock bump 608 maybe formed at the proximal end of connector 600 for use with anactuatable proximal anchor and for connecting to a tether or controlwire, as described above. An optional bulb 610 may be formed at thedistal end of connector 600 to prevent accidental distal slippage of adistal anchor.

In order to reduce material fatigue caused by the heartbeat to heartbeatloading and unloading of the tissue shaping device, the moment ofinertia of connector 600 varies along its length, particularly in theportion of connector disposed between the two anchors. In thisembodiment, for example, connector 600 is formed as a ribbon or sheetand is preferably formed from nitinol having a rectangularcross-sectional area. The thickness of connector 600 is preferablyconstant in the proximal anchor area 602 and the distal anchor area 604to facilitate attachment of crimps and other components of the anchors.The central area 606 has a decreasing thickness (and therefore adecreasing moment of inertia) from the border between, central area 606and proximal anchor area 602 to a point about at the center of centralarea 606, and an increasing thickness (and increasing moment of inertia)from that point to the border between central area 606 and distal anchorarea 604. The varying thickness and varying cross-sectional shape ofconnector 600 change its moment of inertia along its length, therebyhelping distribute over a wider area any strain from the heartbeat toheartbeat loading and unloading of the device and reducing the chance offatigue failure of the connector material.

FIG. 25 shows another embodiment of the connector. Like the previousembodiment, connector 620 has a proximal anchor area 622, a distalanchor area 624 and a central area 626. Proximal anchor area 622 has anoptional two-tined prong 628 formed at its proximal end to facilitateattachment of a crimp and other anchor elements. Bent prong portions 629may be formed at the proximal end of the prong to prevent accidentalslippage of a proximal anchor. An optional bulb 630 may be formed at thedistal end of connector 620 to prevent accidental distal slippage of adistal anchor.

Like the FIG. 24 embodiment, connector 620 is formed as a ribbon orsheet and is preferably formed from nitinol having a rectangularcross-sectional area. The thickness of connector 620 is preferablyconstant in the proximal anchor area 622 and the distal anchor area 624to facilitate attachment of crimps and other components of the anchors.The central area 626 has a decreasing thickness (decreasing moment ofinertia) from the border between central area 626 and proximal anchorarea 622 to a point about at the center of central area 626, and anincreasing thickness (increasing moment of inertia) from that point tothe border between central area 626 and distal anchor area 624. Thevarying thickness and varying cross-sectional shape of connector 620change its moment of inertia along its length, thereby helpingdistribute over a wider area any strain from the heartbeat to heartbeatloading and unloading of the device and reducing the chance of fatiguefailure of the connector material.

FIG. 26 shows a connector 640 in profile. Connector 640 may be formedlike the connectors 600 and 620 or FIGS. 24 and 25, respectively, or mayhave some other configuration. Connector 640 has a proximal anchor area642, a distal anchor area 644 and a central area 646. Connector 640 ispreferably formed as a ribbon or sheet and is preferably formed fromnitinol having a rectangular cross-sectional area.

In the embodiment shown in FIG. 26, the thicknesses of proximal anchorarea 642 and distal anchor area 644 are constant. The thickness ofcentral area 646 decreases from the border between central area 646 andproximal anchor area 642 to a point distal of that border and increasesfrom a point proximal to the border between distal anchor area 644 andcentral area 646 to that border. The points in the central area wherethe thickness decrease ends and the thickness increase begins may becoincident or may be separated to form an area of uniform thicknesswithin central area 646. In this embodiment, the thickness of thecentral area changes as a function of the square root of the distancefrom the borders between the central area and the proximal and distalanchor areas.

FIG. 27 shows yet another embodiment of the connector. As in theembodiment of FIG. 26, connector 650 may be formed like the connectors600 and 620 or FIGS. 24 and 25, respectively, or may have some otherconfiguration. Connector 650 has a proximal anchor area 652, a distalanchor area 654 and a central area 656. Connector 650 is preferablyformed as a ribbon or sheet and is preferably formed from nitinol havinga rectangular cross-sectional area.

In the embodiment shown in FIG. 27, the thicknesses of proximal anchorarea 652 and distal anchor area 654 are constant. The thickness of aproximal portion 658 of central area 656 decreases linearly from theborder between central area 656 and proximal anchor area 652 to aconstant thickness center portion 662 of central area 656, and thethickness of a distal portion 660 of central area 656 increases linearlyfrom center portion 662 to the border between distal anchor area 654 andcentral area 656.

In other embodiments, the thickness of the connector may vary in otherways. In addition, the cross-sectional shape of the connector may beother than rectangular and may change over the length of the connector.

FIGS. 28 and 29 show yet another embodiment of the invention. Tissueshaping device 700 has a connector 706 disposed between a proximalanchor 702 and a distal anchor 704. Connector 706 may be formed as aribbon or sheet, such as the tapered connectors shown in FIGS. 24-27.Actuatable proximal anchor 702 is formed in a figure eight configurationfrom flexible wire such as nitinol and is fastened to connector 706 witha crimp tube 708. Likewise, self-expanding distal anchor 704 is formedin a figure eight configuration from flexible wire such as nitinol andis fastened to connector 706 with a crimp tube 710. A proximal lock bump716 extends proximally from proximal anchor 702 for use in actuating andlocking proximal anchor 702 and for connecting to a tether or controlwire, as described above.

Bending points 712 are formed in the loops of proximal anchor 702, andbending points 714 are formed in the loops of distal anchor 704. Whencompressed into their unexpanded configurations for catheter-baseddelivery and deployment or for recapture into a catheter forredeployment or removal, the wire portions of anchors 702 and 704 bendabout bending points 712 and 714, respectively, to limit thecross-sectional profile of the anchors within the catheter. The bendingpoints also affect the anchor strength of the anchors and theadaptability of the anchors to different vessel diameters, as discussedabove.

In addition to different coronary sinus lengths and varying distancesfrom the ostium to the crossover point between the coronary sinus andthe circumflex artery, the diameter of the coronary sinus at the distaland proximal anchor points can vary from patient to patient. The anchorsdescribed above may be made in a variety of heights and combined withconnectors of varying lengths to accommodate this patient to patientvariation. For example, tissue shaping devices deployed in the coronarysinus to treat mitral valve regurgitation can have distal anchor heightsranging from about 7 mm. to about 16 mm. and proximal anchor heightsranging from about 9 mm. to about 20 mm.

When treating a patient for mitral valve regurgitation, estimates can bemade of the appropriate length for a tissue shaping device as well asappropriate anchor heights for the distal and proximal anchors. Theclinician can then select a tissue shaping device having the appropriatelength and anchor sizes from a set or sets of devices with differentlengths and different anchor sizes, made, e.g., according to theembodiments described above. These device sets may be aggregated intosets or kits or may simply be a collection or inventory of differenttissue shaping devices.

One way of estimating the appropriate length and anchor sizes of atissue shaping device for mitral valve regurgitation is to view afluoroscopic image of a coronary sinus into which a catheter withfluoroscopically viewable markings has been inserted. The crossoverpoint between the coronary sinus and the circumflex artery can bedetermined as described above, and the screen size of the coronary sinuslength proximal to that point and the coronary sinus diameter at theintended anchor locations can be measured. By also measuring the screendistance of the catheter markings and comparing them to the actualdistance between the catheter marking, the length and diameter measurescan be scaled to actual size. A tissue shaping device with theappropriate length and anchor sizes can be selected from a set orinventory of devices for deployment in the patient to treat mitral valveregurgitation.

FIG. 30 shows yet another embodiment of the method of this invention. Inthis embodiment, a tissue shaping device 800 formed from a substantiallystraight rigid member 802 is disposed in the coronary sinus 804 to treatmitral valve regurgitation. When deployed as shown, the central portionof rigid member 802 exerts a remodeling force anteriorly through thecoronary sinus wall toward the mitral valve 806, while the proximal anddistal ends 808 and 810, respectively, of rigid member 802 exertposteriorly-directed forces on the coronary sinus wall. According tothis invention, device 800 is disposed in relation to the circumflexartery 812 so that all of the anteriorly-directed forces from rigidmember 802 are posterior to the crossover point between artery 812 andcoronary sinus 804, despite the fact that distal end 810 of device 800and a guidewire portion 814 are distal to the crossover point.

The device of FIG. 30 may also include a less rigid portion at thedistal end 810 of member 802 to further eliminate any force directedtoward the mitral valve distal to the crossover point. Further detailsof the device (apart from the method of this invention) may be found inU.S. patent application Ser. No. 10/112,354, published as U.S. patentappl. Publ. No. 2002/0183838, the disclosure of which is incorporatedherein by reference.

FIG. 31 shows another embodiment of the method of this invention. Device900 has a substantially straight rigid portion 902 disposed between aproximal angled portion 904 and a distal angled portion 906 withincoronary sinus 908. As shown, proximal angled portion 904 extendsthrough the coronary sinus ostium 910 within a catheter (not shown).Distal angled portion 906 extends distally to a hooked portion 912 thatis preferably disposed in the AIV.

To treat mitral valve regurgitation, the device's straight portion 902reshapes the coronary sinus and adjacent tissue to apply an anteriorallydirected force through the coronary sinus wall toward the mitral valve914. Due to the device's design, this reshaping force is applied solelyproximal to the crossover point between coronary sinus 908 and thepatient's circumflex artery 916, despite the fact at least a part of thedevice's distal portion 906 and hooked portion 912 are disposed distalto the crossover point.

Other modifications to the inventions claimed below will be apparent tothose skilled in the art and are intended to be encompassed by theclaims.

1. A method of treating regurgitation of a mitral valve in a patient'sheart, the method comprising: delivering a tissue shaping device to thecoronary sinus; and deploying the tissue shaping device to reduce mitralvalve regurgitation, the deploying step comprising applying a forcethrough the coronary sinus wall toward the mitral valve solely proximalto a crossover point where a coronary artery passes between a coronarysinus and the mitral valve.
 2. The method of claim 1 further comprisingdetermining the crossover point.
 3. The method of claim 1 wherein thedelivering step comprises delivering the tissue shaping device to thecoronary sinus in a catheter having an outer diameter no more than tenfrench.
 4. The method of claim 3 wherein the delivering step comprisesdelivering the tissue shaping device to the coronary sinus in a catheterhaving an outer diameter no more than nine french.
 5. The method ofclaim 1 wherein the deploying step comprises placing a distal end of thetissue shaping device proximal to the crossover point.
 6. The method ofclaim 1 wherein the deploying step comprises placing a distal end of thetissue shaping device distal to the crossover point.
 7. The method ofclaim 1 wherein the tissue shaping device comprises a distal anchor, thedeploying step comprising anchoring the distal anchor proximal to thecrossover point.
 8. The method of claim 7 wherein the anchoring stepcomprises expanding the distal anchor.
 9. The method of claim 8 whereinthe anchoring step comprises permitting the distal anchor toself-expand.
 10. The method of claim 8 wherein the anchoring stepcomprises applying an actuation force to the distal anchor.
 11. Themethod of claim 7 wherein the anchoring step comprises anchoring thedistal anchor with an anchoring force of at least one pound.
 12. Themethod of claim 11 wherein the anchoring step comprises anchoring thedistal anchor with an anchoring force of at least two pounds.
 13. Themethod of claim 7 wherein the deploying step further comprises applyinga proximally directed force on the distal anchor.
 14. The method ofclaim 13 wherein the step of applying a proximally directed forcecomprises applying a proximally directed force on the distal anchor fromoutside the patient.
 15. The method of claim 13 wherein the tissueshaping device further comprises a proximal anchor and a connectordisposed between the distal anchor and the proximal anchor, thedeploying step further comprising anchoring the proximal anchor.
 16. Themethod of claim 15 wherein the step of anchoring the proximal anchorcomprises anchoring the proximal anchor in the coronary sinus.
 17. Themethod of claim 15 wherein the step of anchoring the proximal anchorcomprises anchoring the proximal anchor at least partially outside thecoronary sinus.
 18. The method of claim 15 wherein the step of anchoringthe proximal anchor is performed after the step of applying a proximallydirected force on the distal anchor.
 19. The method of claim 15 whereinthe applying step comprises moving the proximal anchor proximally afterthe step of anchoring the distal anchor.
 20. The method of claim 19wherein the step of anchoring the proximal anchor is performed after themoving step.
 21. The method of claim 15 wherein the step of anchoringthe proximal anchor comprises expanding the proximal anchor.
 22. Themethod of claim 21 wherein the anchoring step comprises permitting theproximal anchor to self-expand.
 23. The method of claim 21 wherein theanchoring step comprises applying an actuating force to the proximalanchor.
 24. The method of claim 1 wherein the tissue shaping devicecomprises a distal anchor, the deploying step further comprisingdeploying the distal anchor from a distal end of a catheter.
 25. Themethod of claim 24 further comprising recapturing the distal anchor intoa catheter.
 26. The method of claim 25 further comprising anchoring thedistal anchor after recapturing the distal anchor.
 27. The method ofclaim 1 wherein the tissue shaping device comprises a proximal anchor,the deploying step further comprising deploying the proximal anchor froma distal end of a catheter.
 28. The method of claim 27 furthercomprising recapturing the proximal anchor into a catheter.
 29. Themethod of claim 28 further comprising anchoring the proximal anchorafter recapturing the proximal anchor.
 30. The method of claim 1 whereinthe delivering step comprises delivering the tissue shaping device tothe coronary sinus in a catheter, the deploying step further comprisingdeploying the tissue shaping device from a distal end of the catheter,the method further comprising recapturing the tissue shaping device intoa catheter.
 31. The method of claim 1 further comprising selecting thetissue shaping device from a set of tissue shaping devices comprisingtissue shaping devices of a plurality of lengths prior to the deliveringstep.
 32. The method of claim 1 wherein the tissue shaping devicecomprises an anchor, the method further comprising selecting the tissueshaping device from a set of tissue shaping devices comprising tissueshaping devices of a plurality of anchor sizes prior to the deliveringstep.
 33. A set of devices for use in treating mitral valveregurgitation, the set comprising: a plurality of tissue shaping deviceshaving different lengths, each of the tissue shaping devices beingconfigured to be deliverable to a coronary sinus of a patient within acatheter having an outer diameter no greater than ten french.
 34. Theset of claim 33 further comprising a catheter having an outer diameterno greater than nine french.
 35. The set of claim 33 wherein the tissueshaping devices each comprise an anchor having an unexpandedconfiguration and an expanded configuration, each tissue shaping devicebeing further configured to be deliverable to a coronary sinus of apatient within a catheter having an outer diameter no greater than tenfrench when its distal anchor is in its unexpanded configuration. 36.The set of claim 33 wherein the tissue shaping devices in the set eachcomprise: a proximal anchor having an unexpanded configuration and anexpanded configuration; a distal anchor having an unexpandedconfiguration and an expanded configuration; and a connector disposedbetween the proximal anchor and the distal anchor, each tissue shapingdevice being further configured to be deliverable to a coronary sinus ofa patient within a catheter having an outer diameter no greater than tenfrench when its proximal anchor and distal anchor are in theirunexpanded configurations.
 37. The set of claim 36 wherein at least onetissue shaping device in the set has a length 60 mm or less and at leastone tissue shaping device in the set has a length more than 60 mm. 38.The set of claim 36 wherein the distal anchor of each tissue shapingdevice in the set has a diameter in its expanded configuration equal toor greater than a coronary sinus diameter at a distal anchor location.39. The set of claim 38 wherein the diameters of the distal anchors ofthe tissue shaping devices in the set in their expanded configurationsrange from about 7 mm. to about 16 mm.
 40. The set of claim 36 whereinthe proximal anchor of each tissue shaping device in the set has adiameter in its expanded configuration equal to or greater than acoronary sinus diameter at a proximal anchor location.
 41. The set ofclaim 40 wherein the diameters of the proximal anchors of the tissueshaping devices in the set in their expanded configurations range fromabout 9 mm. to about 20 mm.
 42. The set of claim 36 wherein the distalanchor of each tissue shaping device in the set comprises aself-expanding anchor.
 43. The set of claim 36 wherein the proximalanchor of each tissue shaping device in the set comprises aself-expanding anchor.
 44. The set of claim 36 wherein the distal anchorof each tissue shaping device in the set comprises an actuatable anchor.45. The set of claim 36 wherein the proximal anchor of each tissueshaping device in the set comprises an actuatable anchor.
 46. The set ofclaim 36 wherein the distal anchor of at least one tissue shaping devicein the set comprises a self-expanding anchor and the distal anchor of atleast one tissue shaping device in the set comprises an actuatableanchor.
 47. The set of claim 36 wherein the proximal anchor of at leastone tissue shaping device in the set comprises a self-expanding anchorand the proximal anchor of at least one tissue shaping device in the setcomprises an actuatable anchor.
 48. The set of claim 33 wherein each ofthe tissue shaping devices is configured to be deliverable to a coronarysinus of a patient within a catheter having an outer diameter no greaterthan nine french.
 49. A set of devices for use in treating mitral valveregurgitation, the set comprising: a plurality of tissue shaping deviceseach comprising an anchor having an unexpanded configuration and anexpanded configuration, the anchors having different diameters when intheir expanded configurations, each of the tissue shaping devices beingconfigured to be deliverable to a coronary sinus of a patient within acatheter having an outer diameter no greater than ten french.
 50. Theset of claim 49 wherein the anchor of each device is a distal anchor,the devices each further comprising a proximal anchor having anunexpanded configuration and an expanded configuration, the proximalanchors having different diameters when in their expandedconfigurations.
 51. The set of claim 50 wherein the diameters of thedistal anchors of the tissue shaping devices in the set in theirexpanded configurations range from about 7 mm. to about 16 mm.
 52. Theset of claim 50 wherein the diameters of the proximal anchors of thetissue shaping devices in the set in their expanded configurations rangefrom about 9 mm. to about 20 mm.
 53. The set of claim 52 wherein thedistal anchor of each tissue shaping device in the set comprises aself-expanding anchor.
 54. The set of claim 52 wherein the proximalanchor of each tissue shaping device in the set comprises aself-expanding anchor.
 55. The set of claim 52 wherein the distal anchorof each tissue shaping device in the set comprises an actuatable anchor.56. The set of claim 52 wherein the proximal anchor of each tissueshaping device in the set comprises an actuatable anchor.
 57. The set ofclaim 52 wherein the distal anchor of at least one tissue shaping devicein the set comprises a self-expanding anchor and the distal anchor of atleast one tissue shaping device in the set comprises an actuatableanchor.
 58. The set of claim 52 wherein the proximal anchor of at leastone tissue shaping device in the set comprises a self-expanding anchorand the proximal anchor of at least one tissue shaping device in the setcomprises an actuatable anchor.
 59. The set of claim 49 furthercomprising a catheter having an outer diameter no greater than tenfrench.
 60. The set of claim 49 wherein each of the tissue shapingdevices is configured to be deliverable to a coronary sinus of a patientwithin a catheter having an outer diameter no greater than nine french.